Clinical TrialDepressive DisordersKetaminePlaceboWithdrawn

Ketamine for Preventing Depression in Patients Undergoing Treatment for Pancreatic or Head and Neck Cancers

The primary purpose of this study is to see if it is safe to give patients with pancreatic or head and neck cancer a low dose of the FDA approved anesthetic drug ketamine at the same time they receive radiation and/or chemotherapy for their cancer treatment to prevent depression and its effects.

Target Enrollment
Not specified
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Prospective, single-centre, double-blind, randomised, parallel-group feasibility study of weekly oral ketamine 0.5 mg/kg versus placebo in non-depressed adults with stage II–IV head and neck or stage III–IV pancreatic cancer undergoing curative-intent therapy.

Treatment administered weekly for up to 12 weeks; outcomes include incidence of new-onset depression, anxiety, pain, quality of life, and feasibility/acceptability measures; assessments occur biweekly during treatment and monthly for five months of follow-up.

Study Protocol

Preparation

sessions

Dosing

12 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Weekly oral ketamine 0.5 mg/kg mixed with syrup for 12 weeks

Interventions

  • Ketamine0.5 mg/kg
    via Oral• weekly• 12 doses total

    Mixed with syrup; up to 12 weekly doses

Placebo

inactive

Weekly oral placebo syrup for 12 weeks

Interventions

  • Placebo
    via Oral• weekly• 12 doses total

    Placebo syrup given weekly

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Ability to understand and the willingness to sign a written informed consent.
  • 2. Stage -II-IV epidermoid cancer of the head and neck OR stage III-IV pancreatic cancer, with prognosis of at least three months, per oncologist.
  • 3. Within two weeks of starting or from having started, curative intent therapy for head and neck cancer.
  • 4. Age ≥ 18 years.
  • 5. Adequate liver function as defined by:
  • * ALT < 5 X institutional upper limit of normal (ULN)
  • * AST < 5 X institutional ULN
  • * Total bilirubin < 5 X institutional ULN
  • 6. Both men and women of all races and ethnic groups are eligible for this trial.
  • 7. Use of antidepressants is permitted if dose has been the same for at least 12 weeks prior to study entry if patient still DOES NOT meet exclusion criteria #3.
  • 8. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the study team and her treating physician immediately. Urine pregnancy testing will be done throughout the trial for women of childbearing potential.
  • 9. Must read and understand English fluently.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Receiving another investigational agent on a clinical trial that prohibits participation in other studies of investigational agents.
  • 2. Meets Mini International Neuropsychiatric interview (MINI) criteria for major depression, schizophrenia, bipolar illness, delirium or psychosis.
  • 3. Has moderate to severe depression according to both the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16) score of ≥ 11 AND a Hospital Anxiety and Depression Scale (HADS) Depression subscale score of ≥ 8.
  • 4. Has Suicidal Risk Assessment (SRA) scores ≥ 6.
  • 5. Use of monoamine oxidase inhibitors within 14 days of study entry.
  • 6. Diagnosed with melanoma or lymphoma cancer of the head and neck.
  • 7. Diagnosed with Stage I or II pancreatic cancer or with anticipated survival of less than three months.
  • 8. History of allergic reactions or hypersensitivity to ketamine.
  • 9. Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease.
  • 10. History of significant tachyarrhythmia, severe angina, or myocardial ischemia
  • 11. Poorly controlled hypertension (Systolic Blood Pressure > 180 mmHG or Diastolic Blood Pressure > 100 mmHG), with or without antihypertensives.
  • 12. If a woman is or becomes pregnant or is nursing at any time before or during the treatment period, she will be excluded from the study.
  • 13. Score of ≥ 8 on the WHO Alcohol Use Disorders Identification Test (AUDIT, sensitivity of 0.8).

Study Details

Locations

Cedars-Sinai Medical Center — Los Angeles, California, United States

Your Library